The Principal Systems Engineer will work across engineering functions to implement projects related to aesthetic laser systems and accessories.
He/she will work cross functionally (marketing, clinical, service, manufacturing, regulatory, and quality organizations) to define, architect, and direct the implementation of projects related to aesthetic laser systems and accessories.
He/she will identify and document product requirements and translate product requirements into design specifications.
As part of this responsibility the senior principal systems engineer will develop and maintain the system requirements specification and test plans for the project with emphasis on subsystem interfaces, creating and maintaining system test protocols for design verification and validation and execute testing to prescribed protocols, documenting results and creating final reports.
Knowledge/Educational Requirements
- BS or MS (preferred) in electrical, mechanical, optical, or computer engineering or 8-10 years of equivalent experience
- Minimum of 8 plus years of related experience in systems engineering of complex medical devices
- Advanced knowledge of FDA, IEC and UL standards relating to medical devices
- Familiar with DFx and lean manufacturing concepts
- Define and develop system architectures and perform system analysis
- Define and develop system verification and validation test plans.
Skills and Abilities
- Excellent interpersonal, organizational as well as verbal and written communication skills
- Provide technical leadership on projects
- Strong technical and analytical abilities including DOE, and statistical analysis
- Proficiency with Microsoft Windows Office tools
- Good level familiarity with MS Project and/or Smartsheet
- Familiarity with requirements tools
- Familiarity with Labview, Test Complete, AutoIT or other automation tools
- Familiarity with statistical modeling packages (MathCAD, Matlab, Minitab, Excel)
- Familiarity with high power laser products desirable
- Familiarity with optical modeling, fluid dynamics, heat transfer desirable
- Six sigma knowledge is an advantage
- Familiarity with DF'x and lean manufacturing concepts